Abstract
BackgroundFor the safety monitoring of vaccinations postlicensure, reports of adverse events after immunization (AEFIs) are crucial. New technologies such as digital mobile apps can be used as an active approach to capture these events. We therefore conducted a feasibility study among recipients of the influenza vaccination using an app for assessment of the reporting of AEFIs.ObjectiveThe goal of the research was to determine factors influencing adherence to and correct use of a newly developed app for individuals to report AEFI for 3 months using regular reminder functions, to identify determinants of AEFI occurrence and define reported AEFI types.MethodsWe developed the app (SafeVac) and offered it to recipients of the influenza vaccination in 3 occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFIs were generated through SafeVac for 3 months. Using logistic and Cox regression, we assessed associations between app adherence, correct app entry, AEFIs, and sociodemographic parameters.ResultsOf the individuals who logged into SafeVac, 61.4% (207/337) used the app throughout a 3-month period. App use adherence was negatively associated with female sex (odds ratio [OR] 0.47; CI 0.25-0.91) and correct app entry was negatively associated with older age (OR 0.96; CI 0.93-0.99) and lower education (OR 0.31; CI 0.13-0.76). AEFI occurrence was associated with female sex (hazard ratio 1.41; CI 1.01-1.96) and negatively with older age (hazard ratio 0.98; CI 0.97-0.99). The most common AEFIs reported were injection site pain (106/337), pain in extremity (103/337), and fatigue/asthenia (73/337).ConclusionsDigital AEFI reporting was feasible with SafeVac and generated plausible results for this observation period and setting. Studies directly comparing SafeVac with conventional passive reporting schemes could determine whether such digital approaches improve completeness, timeliness, and sensitivity of vaccine vigilance. Further studies should evaluate if these results are transferable to other vaccinations and populations and if introduction of such a tool has an influence on vaccination readiness and therefore vaccine safety.
Highlights
Vaccinations have been the most effective measure to prevent infectious diseases, preventing over 2 million deaths per year worldwide [1,2]
In Germany, physicians are obliged by law to report suspicions of health impairments that exceed the normal degree of a vaccination to the local health authority (§6 Abs. 1, no. 3, IfSG), which is obliged to report to the Paul Ehrlich Institute (PEI), the Federal Institute for Vaccines and Biomedicines, via phone, mail, fax, or online
The hazard ratio for reporting an influenza-like illness at any time point within 3 months was 0.26 (CI 0.11-0.60) for persons who were vaccinated against influenza in the last year compared with those who were not vaccinated in the last year (Multimedia Appendix 1)
Summary
Vaccinations have been the most effective measure to prevent infectious diseases, preventing over 2 million deaths per year worldwide [1,2]. In a systematic review by Cashman et al [14], only a single participant-centered app capturing AEFIs in near real time was found [15] This clearly shows a general lack of research on an app to report AEFIs, especially in long-term use. For the safety monitoring of vaccinations postlicensure, reports of adverse events after immunization (AEFIs) are crucial New technologies such as digital mobile apps can be used as an active approach to capture these events. Methods: We developed the app (SafeVac) and offered it to recipients of the influenza vaccination in 3 occupational settings in fall 2018 In this prospective longitudinal feasibility study, data on AEFIs were generated through SafeVac for 3 months. Further studies should evaluate if these results are transferable to other vaccinations and populations and if introduction of such a tool has an influence on vaccination readiness and vaccine safety
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